ZA200203755B - Polymorphic form of atorvastatin calcium. - Google Patents

Polymorphic form of atorvastatin calcium. Download PDF

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Publication number
ZA200203755B
ZA200203755B ZA200203755A ZA200203755A ZA200203755B ZA 200203755 B ZA200203755 B ZA 200203755B ZA 200203755 A ZA200203755 A ZA 200203755A ZA 200203755 A ZA200203755 A ZA 200203755A ZA 200203755 B ZA200203755 B ZA 200203755B
Authority
ZA
South Africa
Prior art keywords
atorvastatin
calcium
salt
atorvastatin calcium
solvent
Prior art date
Application number
ZA200203755A
Other languages
English (en)
Inventor
Ari Ayalon
Michal Levinger
Sofia Roytblat
Valerie Niddam
Revital Lifshitz
Judith Aronhime
Original Assignee
Teva Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Teva Pharma filed Critical Teva Pharma
Publication of ZA200203755B publication Critical patent/ZA200203755B/en

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D207/00Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D207/30Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D207/34Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pyrrole Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
ZA200203755A 1999-11-17 2002-05-10 Polymorphic form of atorvastatin calcium. ZA200203755B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US16615399P 1999-11-17 1999-11-17

Publications (1)

Publication Number Publication Date
ZA200203755B true ZA200203755B (en) 2004-05-26

Family

ID=22602039

Family Applications (1)

Application Number Title Priority Date Filing Date
ZA200203755A ZA200203755B (en) 1999-11-17 2002-05-10 Polymorphic form of atorvastatin calcium.

Country Status (20)

Country Link
EP (3) EP2206497A1 (de)
JP (2) JP2003514798A (de)
KR (1) KR20020063190A (de)
CN (1) CN1423634A (de)
AT (2) ATE478665T1 (de)
AU (1) AU783002B2 (de)
CA (1) CA2392096C (de)
CZ (1) CZ20021642A3 (de)
DE (2) DE60044884D1 (de)
ES (2) ES2349364T3 (de)
HR (1) HRP20020429B8 (de)
HU (1) HUP0203257A3 (de)
IL (2) IL149681A0 (de)
PL (1) PL355805A1 (de)
PT (2) PT1235799E (de)
SI (2) SI1235799T1 (de)
SK (1) SK286789B6 (de)
WO (1) WO2001036384A1 (de)
YU (1) YU35802A (de)
ZA (1) ZA200203755B (de)

Families Citing this family (55)

* Cited by examiner, † Cited by third party
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US7411075B1 (en) 2000-11-16 2008-08-12 Teva Pharmaceutical Industries Ltd. Polymorphic form of atorvastatin calcium
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US7501450B2 (en) 2000-11-30 2009-03-10 Teva Pharaceutical Industries Ltd. Crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms
IL156055A0 (en) 2000-11-30 2003-12-23 Teva Pharma Novel crystal forms of atorvastatin hemi calcium and processes for their preparation as well as novel processes for preparing other forms
CA2623600A1 (en) 2000-12-27 2002-07-04 Paul Adrian Van Der Schaaf Crystalline forms of atorvastatin
WO2002057229A1 (en) * 2001-01-19 2002-07-25 Biocon India Limited FORM V CRYSTALLINE [R-(R*,R*)]-2-(4-FLUOROPHENYL)-ß,$G(D)-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1- HEPTANOIC ACID HEMI CALCIUM SALT. (ATORVASTATIN)
CN1524073A (zh) 2001-06-29 2004-08-25 ����-�����ع�˾ ′R-(R*,R*)-2-(4-氟苯基)-β,δ-二羟基-5-(1-甲基乙基)-3-苯基-4-(苯基氨基)羰基-1H-吡咯-1-庚酸钙盐(2∶1)(阿托伐他汀)
CN100471836C (zh) * 2001-07-30 2009-03-25 雷迪实验室有限公司 托伐他汀钙晶型vi和vii
US7074818B2 (en) 2001-07-30 2006-07-11 Dr. Reddy's Laboratories Limited Crystalline forms VI and VII of Atorvastatin calcium
UA77990C2 (en) * 2001-12-12 2007-02-15 Crystalline calcium salt of (2:1) [r-(r*,r*)]-2-(4-fluorophenyl)-?,?-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrroleheptanic acid
AU2003217653A1 (en) * 2002-02-15 2003-09-09 Teva Pharmaceutical Industries Ltd. Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation, as well as novel processes for preparing atorvastatin hemi-calcium forms i, viii and ix
EP1465901A4 (de) 2002-02-19 2006-02-01 Teva Pharma Verfahren zur desolvatation von atorvastatin hemi-kalzium solvaten und von im wesentlichen lösungsmittelfreiem atorvastatin hemi-kalzium
JP2005532362A (ja) * 2002-06-13 2005-10-27 ノバルティス アクチエンゲゼルシャフト インドール誘導スタチンのカルシウム塩
GB0218781D0 (en) 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
EP1572643A2 (de) * 2002-11-28 2005-09-14 Teva Pharmaceutical Industries Ltd. Kristalline form f von atorvastatin hemi calcium salz
EP1424324A1 (de) * 2002-11-28 2004-06-02 Teva Pharmaceutical Industries Limited Kristalline Form F von Atorvastatin
GB0312896D0 (en) 2003-06-05 2003-07-09 Astrazeneca Ab Chemical process
US7790197B2 (en) 2003-06-09 2010-09-07 Warner-Lambert Company Llc Pharmaceutical compositions of atorvastatin
CA2465693A1 (en) * 2003-06-12 2004-12-12 Warner-Lambert Company Llc Pharmaceutical compositions of atorvastatin
US7655692B2 (en) 2003-06-12 2010-02-02 Pfizer Inc. Process for forming amorphous atorvastatin
US20050271717A1 (en) 2003-06-12 2005-12-08 Alfred Berchielli Pharmaceutical compositions of atorvastatin
UY28501A1 (es) 2003-09-10 2005-04-29 Astrazeneca Uk Ltd Compuestos químicos
GB0324791D0 (en) 2003-10-24 2003-11-26 Astrazeneca Ab Chemical process
JP2007536373A (ja) 2004-05-05 2007-12-13 ファイザー・プロダクツ・インク アトルバスタチンの塩形態
CA2701710C (en) 2004-07-20 2013-08-27 Warner-Lambert Company Llc Novel forms of [r-(r*,r*)]-2-(4-fluorophenyl)-.beta.,.delta.-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid calcium salt (2:1)
WO2006037125A1 (en) 2004-09-28 2006-04-06 Teva Pharmaceutical Industries Ltd. Process for preparing forms of atorvastatin calcium substantially free of impurities
EP1716114A1 (de) 2004-10-18 2006-11-02 Teva Pharmaceutical Industries Ltd. Verfahren zur herstellung von amorphem atorvastatin-hemicalcium durch lösen des salzes in einem organischen lösungsmittel, bei dem es sich um eine mischung eines alkohols und eines ketons und/oder eines esters handelt, und entfernen des lösungsmittels
KR20070067175A (ko) 2004-10-28 2007-06-27 워너-램버트 캄파니 엘엘씨 무정형 아토르바스타틴 형성 방법
WO2006048894A1 (en) * 2004-11-05 2006-05-11 Morepen Laboratories Limited Novel crystalline forms of atorvastatin calcium and processes for preparing them.
WO2006054308A2 (en) 2004-11-22 2006-05-26 Dexcel Pharma Technologies Ltd. Stable atorvastatin formulations
CA2499047A1 (en) 2005-03-01 2006-09-01 Apotex Pharmachem Inc. Process for producing atorvastatin hemicalcium
EP1928823B1 (de) 2005-08-15 2014-10-08 Arrow International Limited Verfahren zur Herstellung eines kristallinen ATORVASTATIN Natrium Salzes
AU2006281237A1 (en) 2005-08-15 2007-02-22 Arrow International Limited Crystalline and amorphous sodium atorvastatin
CA2547216A1 (en) 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
EP1808162A1 (de) 2005-11-21 2007-07-18 Teva Pharmaceutical Industries Ltd. Pharmazeutische Formulierung von Atorvastatin
ATE466840T1 (de) 2005-11-21 2010-05-15 Warner Lambert Co Neue formen von är-(r*,r*)ü-2-(4-fluorphenyl)-b,d-dihydroxy-5-( -methylethyl)-3-phenyl-4- ä(phenylamino)carbonylü-1h-pyrrol-1-heptansäure magnesium
EP1923057A1 (de) 2005-11-21 2008-05-21 Teva Pharmaceutical Industries Ltd Pharmazeutische Atorvastatin-Formulierung
CN101370774A (zh) 2005-12-13 2009-02-18 特瓦制药工业有限公司 阿托伐他汀半钙的晶形及其制备方法
EP1810667A1 (de) 2006-01-20 2007-07-25 KRKA, tovarna zdravil, d.d., Novo mesto Pharmazeutische Zusammensetzung enthaltend amorphes Atorvastatin
AU2007219107B2 (en) * 2006-02-22 2012-12-06 Mylan Laboratories Ltd. New crystalline form of Atorvastatin hemi-calcium
US7915302B2 (en) * 2007-03-02 2011-03-29 Dong-A Pharm. Co., Ltd. Crystal forms of pyrrolylheptanoic acid derivatives
CA2694242C (en) 2007-06-29 2013-10-01 Generics [Uk] Limited Process for introduction of hydroxyethoxy side chain in bosentan
US20100260851A1 (en) * 2007-07-11 2010-10-14 Actavis Group Ptc Ehf Novel Polymorph of Atorvastatin Calcium and Use Thereof for the Preparation of Amorphous Atorvastatin Calcium
WO2009053748A2 (en) 2007-10-24 2009-04-30 Generics [Uk] Limited Novel crystalline forms
ES2650247T3 (es) 2008-02-08 2018-01-17 Generics [Uk] Limited Procedimiento de preparación del bosentán
AU2009321375A1 (en) 2008-11-03 2010-06-03 Generics [Uk] Limited HPLC method for the analysis of bosentan and related substances and use of these substances as reference standards and markers
EP2327682A1 (de) * 2009-10-29 2011-06-01 KRKA, D.D., Novo Mesto Verwendung von amphiphilen Verbindungen zur gesteuerten Kristallisation von Statinen und Statin Zwischenprodukte.
SI2373609T1 (sl) * 2008-12-19 2013-12-31 Krka, D.D., Novo Mesto Uporaba amfifilnih spojin za kontrolirano kristalizacijo statinov in intermediatov statinov
CZ201039A3 (cs) 2010-01-19 2011-07-27 Zentiva, K. S Zpusob prumyslové výroby amorfní formy hemivápenaté soli (3R,5R) 7-[3-fenyl-4-fenylkarbamoyl-2-(4-fluorfenyl)-5-isopropylpyrrol-1-yl]-3,5-dihydroxyheptanové kyseliny (atorvastatinu) s vysokým specifickým povrchem a jeho použití v lékové forme
KR20120011249A (ko) 2010-07-28 2012-02-07 주식회사 경보제약 아토바스타틴 헤미칼슘염의 신규한 결정형, 이의 수화물, 및 그의 제조방법
CN102249978A (zh) * 2011-06-09 2011-11-23 浙江金立源药业有限公司 阿托伐他汀钙的ky晶型及制备方法
CN103483238B (zh) * 2013-08-20 2014-12-31 蚌埠丰原医药科技发展有限公司 阿托伐他汀钙三水合物的制备方法
RU2021125455A (ru) 2013-11-15 2021-10-05 Экебиа Терапьютикс, Инк. Твердые формы { [5-(3-хлорфенил)-3-гидроксипиридин-2-карбонил]амино} уксусной кислоты, их композиции и применения
CN104945300B (zh) * 2015-06-17 2017-05-10 北京嘉林药业股份有限公司 一种ⅰ型阿托伐他汀钙的纯化方法
CN105085362B (zh) * 2015-09-18 2018-01-05 浙江海森药业有限公司 高纯度结晶型阿托伐他汀钙的制备方法

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Also Published As

Publication number Publication date
SK6742002A3 (en) 2003-05-02
HRP20020429B1 (en) 2006-05-31
DE60018100D1 (en) 2005-03-17
AU783002B2 (en) 2005-09-15
ES2234699T3 (es) 2005-07-01
YU35802A (sh) 2005-07-19
ES2349364T3 (es) 2010-12-30
JP2009102439A (ja) 2009-05-14
KR20020063190A (ko) 2002-08-01
CA2392096A1 (en) 2001-05-25
EP1535613A2 (de) 2005-06-01
DE60018100T2 (de) 2005-09-15
DE60044884D1 (de) 2010-10-07
WO2001036384A1 (en) 2001-05-25
HRP20020429A2 (en) 2004-04-30
PL355805A1 (en) 2004-05-17
HUP0203257A2 (hu) 2003-01-28
AU1617301A (en) 2001-05-30
IL149681A (en) 2007-06-17
PT1535613E (pt) 2010-10-04
CN1423634A (zh) 2003-06-11
HUP0203257A3 (en) 2003-05-28
EP1535613B1 (de) 2010-08-25
CA2392096C (en) 2008-07-15
ATE478665T1 (de) 2010-09-15
PT1235799E (pt) 2005-05-31
SK286789B6 (sk) 2009-05-07
EP1235799A1 (de) 2002-09-04
HRP20020429B8 (en) 2007-03-31
ATE288893T1 (de) 2005-02-15
EP1535613A3 (de) 2005-08-31
EP1235799B1 (de) 2005-02-09
SI1535613T1 (sl) 2010-12-31
EP2206497A1 (de) 2010-07-14
SI1235799T1 (en) 2005-06-30
IL149681A0 (en) 2002-11-10
EP1235799A4 (de) 2003-05-28
CZ20021642A3 (cs) 2003-05-14
JP2003514798A (ja) 2003-04-22

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